McDonald criteria

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Animation showing dissemination of multiple sclerosis lesions in time and space as demonstrated by monthly MRI studies along a year

The McDonald criteria are diagnostic criteria for multiple sclerosis (MS). These criteria are named after neurologist W. Ian McDonald. In April 2001, an international panel in association with the National Multiple Sclerosis Society (NMSS) of America recommended revised diagnostic criteria for MS. They have undergone revisions in 2005[1] and 2010.[2]

McDonald criteria try to prove the existence of demyelinating lesions disseminated in time (DIT) and space (DIS) using only clinical and paraclinical techniques, including advances in magnetic resonance imaging (MRI). These criteria are intended to replace the Poser criteria and the older Schumacher criteria. They discourage the previously used Poser terms such as "clinically definite" and "probable MS", and propose as diagnostic either "MS", "possible MS", or "not MS".[3]

The new criteria facilitate the diagnosis of MS in patients who present early signs and symptoms suggestive of the disease. These include monosymptomatic disease, disease with a typical relapsing-remitting course or insidious progression but no clear attacks and remissions.

The McDonald criteria for the diagnosis of multiple sclerosis were revised first in 2005 to clarify exactly what is meant by an "attack", "dissemination" and a "positive MRI", etc.[1] Later they were revised again in 2010.

McDonald's criteria are the standard clinical case definition for MS and the 2010 version is regarded as the gold standard test for MS diagnosis.[citation needed]

Diagnostic Criteria[edit]

Clinical Presentation Additional Data Needed
* 2 or more attacks (relapses)
* 2 or more objective clinical lesions
None; clinical evidence will suffice (additional evidence desirable but must be consistent with MS)
* 2 or more attacks
* 1 objective clinical lesion
Dissemination in space, demonstrated by:
* MRI
* or a positive (cerebrospinal fluid) CSF and 2 or more MRI lesions consistent with MS
* or further clinical attack involving different site
* 1 attack
* 2 or more objective clinical lesions
Dissemination in time, demonstrated by:
* MRI
* or second clinical attack
* 1 attack
* 1 objective clinical lesion
(monosymptomatic presentation)
Dissemination in space demonstrated by:
* MRI
* or positive CSF and 2 or more MRI lesions consistent with MS
and
Dissemination in time demonstrated by:
* MRI
* or second clinical attack
Insidious neurological progression
suggestive of MS
(primary progressive MS)
One year of disease progression (retrospectively or prospectively determined) and

Two of the following:

a. Positive brain MRI (nine T2 lesions or four or more T2 lesions with positive VEP)
b. Positive spinal cord MRI (two focal T2 lesions)
c. Positive CSF

They discourage the previously used terms such as "clinically definite" and "probable MS", and propose as diagnostic either "MS", "possible MS", or "not MS".[3]

Criticism[edit]

McDonald criteria seems to rely on a definition of MS based solely in the presence of demyelinating lesions and its dissemination in time and space, regardless of the nature of the lesions, being therefore non-specific. They address the problem of specificity requiring that "no better explanation" is found for the lesions. This converts MS in some kind of default diagnosis for demyelinating diseases that produce lesions. Besides, they consider as MS just the presence of the lesions, and not the underlying condition that produces them.

Sensitivity and specificity of the criteria respect autopsy confirmation cannot be evaluated during the initial presentations. When autopsy is available, normally the lesions of the patient are very old to evaluate the initial diagnosis. In the few cases of people dying during their initial stages the disease is normally to strong to be considered typical. On the other hand, the most time that a patient is followed, the most certain the diagnosis is (being 100% after death). Therefore sensitivity and specificity are normally evaluated retrospectively by stages, following the patients during the course of the disease evolution. A normal milestone is to check if the CIS converts to CDMS in a given number of years.

In any case, sensitivity of McDonald's criteria is low respect pathological MS because of around the 25% of the MS cases are silent silent MS cases[4] even with two or more pathologically disseminated lesions. Positives during the CIS are rare (McDonald positive is nearly incompatible with CIS definition) but retrospective MRI shows that there is normally more than one pathological lesion when the CIS appears. Therefore the sensitivity is expected to be low in the initial stages.

Specificity is also very low due that nature of the lesions is not considered, but only their dissemination. None of the criteria is MS-specific. In order to reduce the false positives, McDonald et al. propose that their criteria should be applied only after any other disease has been discarded.[3] Currently sensitivity and specificity are estimated around 46% and 63% respect the criterium "conversion to definite in 40 months".[5] Currently, the best predictor of future development of clinical multiple sclerosis is the number of T2 lesions visualized by magnetic resonance imaging after the CIS.[6]

Asiatic populations[edit]

McDonald criteria have been shown to have a low sensitivity and specificity (with respect to the pathological presence of lesions) in Asiatic populations.[7][8] They have good predictive behaviour (with respect to CIS [clinically isolated syndrome] to CDMS [Clinically Definite Multiple Sclerosis] conversion) when evaluated in non-selected populations.[9]

clinical point of view[edit]

There is an ongoing discusion about whether MS should be considered a pathological or clinical entity. The original article of McDonald states that "MS is a clinical entity and therefore should be diagnosized [sic] with clinical and paraclinical criteria".[3] Nevertheless, they acknowledge the existence of lesion-based MS definition, saying in their introduction "The International Panel on MS Diagnosis presents revised diagnostic criteria for multiple sclerosis (MS). The focus remains on the objective demonstration of dissemination of lesions in both time and space".[3] Besides, they acknowledge that other groups work using pathological definitions saying that for them "the only proved diagnosis of MS can be made upon autopsy, or occasionally upon biopsy, where lesions typical of MS can be directly detected through standard histopathological techniques".[3] According to Hans Lassmann, a more accurate pathological definition should be used because the dissemination in time and space criterium has problems with differential diagnosis.[10] Some groups propose to use the presence of central veins visible under MRI to improve the diagnosis.[11] Besides, subclinical MS cases would be always false negatives as MS cases by these criteria.[12]

For those that consider MS a clinical condition the diagnosis criteria is the definition of the disease. For others, they diagnosis criteria are just a tool and the disease should be defined pathologically.

2010 Revisions[edit]

In 2010, the International Panel on Diagnosis of MS met in Dublin, Ireland for a third time to discuss and revise the McDonald diagnostic criteria above.[2] Reasons for revisions to the criteria included the simplification of demonstration of CNS lesions in space and time via imaging, and the above criticisms that the previous criteria did not appropriately apply to non-Western Caucasian populations.[2]

One study has suggested that the new criteria allow a faster diagnosis, but with slight sacrifice in accuracy.[13]

Revised Diagnostic Criteria (2010)[edit]

Clinical Presentation Additional Data Needed
* 2 or more attacks (relapses)
* 2 or more objective clinical lesions
None; clinical evidence will suffice (additional evidence desirable but must be consistent with MS)
* 2 or more attacks
* 1 objective clinical lesion
Dissemination in space, demonstrated by:
* MRI
* or further clinical attack involving different site.
New criteria: Dissemination in Space (DIS) can be demonstrated by the presence of 1 or more T2 lesions in at least 2 of 4 of the following areas of the CNS: Periventricular, Juxtacortical, Infratentorial, or Spinal Cord.
* 1 attack
* 2 or more objective clinical lesions
Dissemination in time (DIT), demonstrated by:
* MRI
* or second clinical attack
New criteria: No longer a need to have separate MRIs run; Dissemination in time, demonstrated by: Simultaneous presence of asymptomatic gadolinium-enhancing

and nonenhancing lesions at any time; or A new T2 and/or gadolinium-enhancing lesion(s) on follow-up MRI, irrespective of its timing with reference to a baseline scan; or Await a second clinical attack. [This allows for quicker diagnosis without sacrificing specificity, while improving sensitivity.]

* 1 attack
* 1 objective clinical lesion
(clinically isolated syndrome)
New criteria: Dissemination in space and time, demonstrated by:

For DIS: 1 or more T2 lesion in at least 2 of 4 MS-typical regions of the CNS (periventricular, juxtacortical, infratentorial, or spinal cord); or Await a second clinical attack implicating a different CNS site; and For DIT: Simultaneous presence of asymptomatic gadolinium-enhancing and nonenhancing lesions at any time; or A new T2 and/or gadolinium-enhancing lesion(s) on follow-up MRI, irrespective of its timing with reference to a baseline scan; or Await a second clinical attack.

Insidious neurological progression
suggestive of MS
(primary progressive MS)
New criteria: One year of disease progression (retrospectively or prospectively determined) and

two or three of the following:
1. Evidence for DIS in the brain based on 1 or more T2 lesions in the MS-characteristic (periventricular, juxtacortical, or infratentorial) regions
2. Evidence for DIS in the spinal cord based on 2 or more T2 lesions in the cord
3. Positive CSF (isoelectric focusing evidence of oligoclonal bands and/or elevated IgG index)

References[edit]

  1. ^ a b Polman, CH; Reingold, SC; Edan, G; Filippi, M; Hartung, HP; Kappos, L; Lublin, FD; Metz, LM; McFarland, HF; O'Connor, PW; Sandberg-Wollheim, M; Thompson, AJ; Weinshenker, BG; Wolinsky, JS (December 2005). "Diagnostic criteria for multiple sclerosis: 2005 revisions to the "McDonald Criteria".". Annals of neurology 58 (6): 840–6. doi:10.1002/ana.20703. PMID 16283615. 
  2. ^ a b c Polman, CH; Reingold, SC; Banwell, B; Clanet, M; Cohen, JA; Filippi, M; Fujihara, K; Havrdova, E; Hutchinson, M; Kappos, L; Lublin, FD; Montalban, X; O'Connor, P; Sandberg-Wollheim, M; Thompson, AJ; Waubant, E; Weinshenker, B; Wolinsky, JS (February 2011). "Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonald criteria.". Annals of neurology 69 (2): 292–302. doi:10.1002/ana.22366. PMC 3084507. PMID 21387374.  Cite uses deprecated parameter |coauthors= (help)
  3. ^ a b c d e f McDonald WI, Compston A, Edan G, et al. (2001). "Recommended diagnostic criteria for multiple sclerosis: guidelines from the International Panel on the diagnosis of multiple sclerosis" (PDF). Ann. Neurol. 50 (1): 121–7. doi:10.1002/ana.1032. PMID 11456302. 
  4. ^ Engell T (May 1989). "A clinical patho-anatomical study of clinically silent multiple sclerosis". Acta Neurol Scand 79 (5): 428–30. doi:10.1111/j.1600-0404.1989.tb03811.x. PMID 2741673. 
  5. ^ Swanton J K; et al. (2006). "Modification of MRI criteria for multiple sclerosis in patients with clinically isolated syndromes". J Neurol Neurosurg Psychiatry 77 (7): 830–833. doi:10.1136/jnnp.2005.073247. 
  6. ^ Cramer SP, Modvig S, Simonsen HJ, Frederiksen JL, Larsson HB (Jul 2015). "Permeability of the blood-brain barrier predicts conversion from optic neuritis to multiple sclerosis". Brain 138: 2571–83. doi:10.1093/brain/awv203. PMID 26187333. 
  7. ^ HT Chong et al (2006) Proposed modifications to McDonald diagnostic criteria for Asians with multiple sclerosis, Neurology Asia 11:87–90
  8. ^ Chong, H; Kira, J; Tsai, C; Ong, B; Li, P; Kermode, A; Tan, C (19 June 2009). "Proposed modifications to the McDonald criteria for use in Asia". Multiple Sclerosis 15 (7): 887–888. doi:10.1177/1352458509104587. 
  9. ^ Fortini, Alexandre S.; Sanders, Elizabeth L.; Weinshenker, Brian G.; Katzmann, Jerry A. (1 November 2003). "Cerebrospinal Fluid Oligoclonal Bands in the Diagnosis of Multiple Sclerosis Isoelectric Focusing With IgG Immunoblotting Compared With High-Resolution Agarose Gel Electrophoresis and Cerebrospinal Fluid IgG Index". American Journal of Clinical Pathology 120 (5): 672–675. doi:10.1309/Y5VFF2UAW0RK5W63. PMID 14608891. 
  10. ^ Lassmann, H (2 February 2010). "Acute disseminated encephalomyelitis and multiple sclerosis". Brain 133 (2): 317–319. doi:10.1093/brain/awp342. PMID 20129937. 
  11. ^ University of Nottingham, Press Release, New MRI technique offers faster diagnosis of multiple sclerosis [1]
  12. ^ McDonnell, G.V.; Cabrera-Gomez, J; Calne, D.B.; Li, D.K.B.; Oger, J (1 March 2003). "Clinical presentation of primary progressive multiple sclerosis 10 years after the incidental finding of typical magnetic resonance imaging brain lesions: The subclinical stage of primary progressive multiple sclerosis may last 10 years". Multiple Sclerosis 9 (2): 204–209. doi:10.1191/1352458503ms890cr. PMID 12708816. 
  13. ^ Runia, TF; Jafari, N; Hintzen, RQ (Dec 2013). "Application of the 2010 revised criteria for the diagnosis of multiple sclerosis to patients with clinically isolated syndromes.". European journal of neurology : the official journal of the European Federation of Neurological Societies 20 (12): 1510–6. doi:10.1111/ene.12243. PMID 23906114.